Sorafenib in the first line treatment of advanced hepatocellular carcinoma with ChildPugh liver function class B. Multicentre phase 3 randomized trial - BOOST

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013870-42-IT

Enrollment

510

Registered

2009-10-05

Start date

2011-10-11

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced hepatocellular carcinoma with ChildPugh liver function class B MedDRA version: 9.1 Level: LLT Classification code 10024720

Interventions

Trade Name: NEXAVAR*112CPR RIV 200MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Sorafenib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients with diagnosis of HCC according to the AASLD- EASL criteria (10) ? Age >18 years ? Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments) ? Liver function classified as Child class B ? ECOG performance status ? 2 ? Adequate renal (creatinine ? 1.5 x ULN), and haematological function (platelet count ? 60 x 10^9/L, hemoglobin ? 9 g/dl) ? Life expectancy of at least 2 months ? Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Prior exposure to sorafenib ? Performance Status (ECOG) ?3 ? Concomitant diseases that contraindicates the use of sorafenib ? Gastro-intestinal bleeding in the previous 30 days ? Serious active infections (> grade 2 CTCAE version 3.0) ? Pregnant or lactating women ? Not cooperative patients ? Inability of patients to access to the hospital ? Grade 3-4 encephalopathy that makes the patient not able to follow study procedures (Table 2) ? Refusal of informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: to compare two doses of sorafenib (800 and 400 mg/day) with best supportive care in terms of survival in HCC patients with impaired liver function (Child B).;Secondary Objective: to compare the three treatment arms in terms of toxicity and quality of life.;Primary end point(s): OVERALL SURVIVAL	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026